BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACELABS TELEMETRY RECIEVER HOUSING

    MDR report key: 6202523 · Received December 23, 2016

    Report

    Report Number
    3010157426-2016-00201
    Event Type
    Malfunction
    Date Received
    December 23, 2016
    Date of Event
    November 27, 2016
    Report Date
    January 24, 2017
    Manufacturer
    SPACELABS HEALTHCARE INC.
    Product Code
    DSI
    PMA / PMN Number
    K925510
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    MONITORING RESUMED WITH THE USE OF A LOANER DEVICE AND THE CUSTOMER¿S DEVICE WAS SENT IN FOR REPAIR. SPACELABS HAS LAUNCHED AN INVESTIGATION AND WILL FILE A SUPPLEMENTAL REPORT ONCE THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RECEIVED AT SPACELABS¿ EQUIPMENT SERVICE CENTER FOR REPAIR. THE REPORTED PROBLEM WAS VERIFIED, AND THE POWER SUPPLY PCBA WAS REPLACED. THE REPAIRED UNIT PASSED ALL FUNCTIONAL TESTS AND WAS RETURNED TO THE CUSTOMER. THIS REPORT IS COMPLETE AND THIS PARTICULAR ISSUE IS CONSIDERED CLOSED.

    Description of Event or Problem · 1

    SPACELABS RECEIVED A REPORT THAT ON (B)(6) 2016, A LOSS OF TELEMETRY MONITORING OCCURRED AT THE CENTRAL MONITOR. NO INJURY WAS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    853128 SPACELABS TELEMETRY RECIEVER HOUSING TELEMETRY HOUSING DSI SPACELABS HEALTHCARE INC. 90479

    Patients

    Seq Age Sex Outcome Treatment
    1 91387